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European regulators have granted Sphere Medical CE Mark approval for its Proxima Generation 2 device as an in vitro diagnostic tool. The approval comes after it was reported last month that the device proved to be as effective as point-of-care and laboratory blood gas analyzers in tracking arterial blood in a clinical environment.

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Sphere Medical's Proxima 3 device showed comparable performance to lab-based and point-of-care blood gas analyzers used in a clinical environment, according to a U.K. study of 105 blood samples from 18 surgical patients. The company is gearing up to obtain CE mark approval for the device, which could be released in the U.K. in the first half of next year, CEO Stuart Hendry said.

Symetis' Acurate TA device, a second-generation transcatheter aortic valve implant already approved in Europe, showed a 98% rate of procedural success and minimal valve leakage in a 250-patient clinical study. The device also showed a 6.8% all-cause mortality rate at 30 days, which the company said was one of the lowest rates reported for TAVI devices.

Arrowhead Medical Device Technologies has announced the release of a second-generation version of its Arrow-Lok digital fusion device, which earned 510(k) clearance from the FDA late last year. The technology is used for the treatment and repair of a common foot illness called proximal interphalangeal joint flexion deformity, or hammertoe.

Sphere Medical has obtained CE mark approval in Europe to market Pelorus 1500, a point-of-care in vitro diagnostic tool tailored for use by anesthetists in critical care environments. The device, which rapidly measures the concentration of propofol in blood samples, allows doses of the intravenous anesthetic to be personalized for each patient.

Delcath Systems has earned CE mark approval to market in Europe a second-generation hemofiltration cartridge used with its Hepatic CHEMOSAT delivery system. The new product allows doctors to use the CHEMOSAT device for the percutaneous intra-arterial delivery of melphalan hydrochloride to the liver of patients who they think need the therapy.